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Botulinum Toxin for Stomach Cancer Treatment
This study has been completed.
Sponsor:
St. Olavs Hospital
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT01822210
First received: March 21, 2013
Last updated: July 11, 2016
Last verified: July 2016
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Purpose
Preclinical studies at our institution, using a genetic mouse model of gastric cancer, strongly suggest that innervation of the stomach wall is required not only for the development, but also for the progression of gastric cancer, and that denervation of the stomach either by vagotomy or by injection of botulinum toxin (Botox®) in the stomach wall may represent an effective therapeutic intervention. New treatment options for inoperable cancer in the stomach are urgently needed, and local treatment with botulinum toxin seems to be an attractive possibility. In this pilot study Botox injections will be given by gastroscopy in both the tumor and the surrounding stomach wall. The purpose of the study is to obtain data needed to calculate sample size in a larger controlled trial.
| Condition | Intervention | Phase |
|---|---|---|
| Stomach Neoplasms | Drug: Botox | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Botulinum Toxin (BOTOX) for Stomach Cancer Treatment |
Resource links provided by NLM:
Further study details as provided by St. Olavs Hospital:
Primary Outcome Measures:
- Change of tumor volume in the stomach. [ Time Frame: Baseline and 8 weeks ]Change measured with a standardized CT protocol (Thickness of the stomach wall and diameter of the tumor).
- Change of tumor volume in the stomach. [ Time Frame: 8 weeks and 20 weeks ]Change measured with a standardized CT protocol (Thickness of the stomach wall and diameter of the tumor).
Secondary Outcome Measures:
- Toxicity [ Time Frame: 2 weeks ]Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- Toxicity [ Time Frame: 8 weeks ]Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- performance status [ Time Frame: 2 weeks ]ECOG scale
- performance status [ Time Frame: 8 weeks ]ECOG scale
- performance status [ Time Frame: 20 weeks ]ECOG scale
| Enrollment: | 7 |
| Study Start Date: | January 2013 |
| Study Completion Date: | May 2016 |
| Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Botox
Injection of Botox in the tumor and surrounding stomach wall.
|
Drug: Botox
injection by gastroscopy (100 Allergen units)
Other Name: Botulinum toxin
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
Patients with verified gastric adenocarcinoma but found non-resectable or inoperable after evaluation in the appropriate multidisciplinary team at St.Olav Hospital. Trondheim University Hospital. The inclusion criteria for such patients are:
- Patients who have received 1.line and 2. line chemotherapy but no longer respond to such therapy.
- Patients who, due to toxicity of chemotherapy, cannot be offered such treatment.
- Patients who, after meticulous information about chemotherapy, still do not want such treatment.
- Patients with performance status (ECOG) 0-2.
Exclusion criteria:
- Known allergy to any of the components in Botox®
- Known peripheral motor neuropathy disease ( for example: Amyotrophic Lateral Sclerosis, ALS), or subclinical or clinical deficiency of neuromuscular transmission (for example: Myasthenia Gravis or Eaton-Lambert`s Syndrome).
- Pregnant or lactating women.
- Another cancer disease that is not under control.
- Another concomitant treatment for cancer.
- Serious mental illness.
- Performance status (ECOG) 3-4.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01822210
Please refer to this study by its ClinicalTrials.gov identifier: NCT01822210
Locations
| Norway | |
| Department of Gastrointestinal Surgery, St Olavs Hospital Trondheim University Hospital | |
| Trondheim, Norway | |
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
| Principal Investigator: | Jon Erik Grønbech, MD. PhD. | St. Olavs Hospital |
More Information
| Responsible Party: | St. Olavs Hospital |
| ClinicalTrials.gov Identifier: | NCT01822210 History of Changes |
| Other Study ID Numbers: |
StOlav2205 2012-002493-31 ( EudraCT Number ) |
| Study First Received: | March 21, 2013 |
| Last Updated: | July 11, 2016 |
Keywords provided by St. Olavs Hospital:
|
Botulinum Toxins Injections Stomach Tomography, X-Ray Computed |
Additional relevant MeSH terms:
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Botulinum Toxins onabotulinumtoxinA |
Botulinum Toxins, Type A abobotulinumtoxinA Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on August 18, 2017